Area Lyme disease sufferers condemn CDC's test protocol

Sunday

Jun 22, 2014 at 6:00 AMJun 22, 2014 at 1:32 PM

By Craig S. Semon TELEGRAM & GAZETTE STAFF

Patricia "Trish" A. McCleary of Sturbridge is co-founder of S.L.A.M. Sturbridge Lyme Awareness of Massachusetts and a member of the Massachusetts Lyme Legislative Task Force. She is also a Lyme disease sufferer.

Not only was she bedridden for two-and-a-half years because of the disease, Ms. McCleary said she was misdiagnosed even longer.

"When I was still paralyzed, I was sent away from every hospital in Boston and they all said, 'Oh it's all in your head,' " Ms. McCleary recalled. "I went to see a therapist for this 'psychiatric problem' and she took one look at me and said, 'Oh my God, this is the worse case of Lyme I've seen yet.' And she picked up the phone right then and got me to a doctor in Connecticut who took one look at me and was horrified…I thought, how on Earth could every hospital in Boston that we have been to not know this?"

Ms. McCleary, who has been in remission since 2009, chastises the Centers for Disease Control and Prevention for its two-tier test system, using ELISA (enzyme-linked immunosorbent assay), which measures a person's antibody (or immune response) to the bacteria that causes Lyme disease; and Western blot, which looks for antibodies the body makes against different molecules, or "antigens," that are part of the Borrelia burgdorferi (Lyme disease) bacteria.

"ELISA is maybe 50 percent accurate," Ms. McCleary said. "For any other disease, that would be unacceptable. And, if it doesn't come out positive, you don't get treatment. Could you imagine if ELISA was the test for cancer?"

Ms. McCleary claims the Western blot test is faulty because the CDC is not using two "most Lyme specific" bands (31 kDa and 34 kDa) in its test. And she isn't the only area Lyme disease sufferer or advocate that has disdain for the CDC's test methods and practices.

Michele Miller and her husband, Ken, both of Worcester, founded the Central Massachusetts Lyme Foundation in honor of her mother, Jeanne Cloutier of Auburn, who, after years of being misdiagnosed, died last year from late-stage Lyme.

"The CDC needs to recognize the bands for the Western blot that are Lyme disease-related and they're not doing that," Mrs. Miller said. "Some people, even if they have two bands or some that are indeterminate, if they've been exposed to Lyme and that Western blot shows that, per the CDC, if less than two bands are positive, then by the CDC standards, it's not a positive test."

Massachusetts Lyme Legislative Task Force member Michelle Treseler has a message for CDC officials: "If you want the public to avoid tests that aren't endorsed by your organization, then provide a test that is reliable and accurate."

"Currently, with the testing that the CDC recommends, patients will not test positive for the first few weeks of illness and will often test negative, as there are not sufficient antibodies to be detected," Ms. Tresele said. "If a doctor waits to treat until the test shows positive, then it allows the illness to get a huge head start and, potentially, a strong foothold before being treated. Lyme disease requires early treatment."

Ms. Treseler, who is a Lyme disease sufferer (and was treated for lupus or a "lupus-like" condition for many years before being diagnosed with Lyme), said the ELISA test is "unreliable" and "unacceptable."

"By definition, a screening test should have at least 95 percent sensitivity. (The ELISA has only 65 percent sensitivity, she said.) If this was the most reliable test say for other illnesses, such as HIV, this would be an absolute outrage," Ms. Treseler said. "The current two-tiered testing recommended by the CDC is abysmal. The fact of the matter is there are no accurate tests. There are no tests available to prove that the bacteria is eradicated or that the patient is cured."

Ms. Treseler said the Western blot may be helpful in aiding physicians to make a clinical diagnosis, but only if the bands 31 kDa and 34 kDa are reported.

But not all Lyme disease advocates agree with the Lyme disease sufferers.

Massachusetts Lyme Commission member Sam R. Telford III, who is also a commission member and professor in the department of the biomedical sciences and infectious diseases at Cummings School of Veterinary Medicine at Tufts University in North Grafton, said the CDC-endorsed Lyme disease tests have gotten a bad rap, largely as a result of "inappropriate use."

"When someone comes in a couple weeks after being in the bushes and being exposed to ticks and they got a fever, chills, muscles, aches and the rash, there's no need for a test. And not only that, if you test that person, they will be negative because the body has not had a chance to generate the antibodies the test detects," Mr. Telford said. "There are also people who get acute Lyme disease or early Lyme disease and they test negative after having been treated. Well, that means the drugs have done their job and aborted a further development of the antibody response."

Furthermore, Mr. Telford said today's Lyme disease tests are only as good as the people prescribing them. Mr. Telford said the public is too quick to blame Lyme disease for everything that ails us.

"There are people out there with vague signs and symptoms that could be consistent with Lyme disease but could be also consistent with the general process of aging or anything else and they are convinced they have Lyme disease," Mr. Telford said. "Their doctor sends off the test and it comes back negative from all of the mainstream large laboratories and they go, 'How can this be? I have Lyme disease. The test must be no good,' while a scientist will look at the test and say, 'Well, maybe the diagnosis was incorrect.' And, then they go off to an alternative testing service which more often than not, because they interpret their test a little differently, will say, 'Oh, no, you're actually positive.' "

Mr. Telford said "appropriate use" for Lyme disease tests is a month after possibly contracting the disease.

However, people who have been treated will often come up negative, so there is really no need for the testing then, because the person has, presumably, gotten better, he said.

"Lyme disease is what we call a clinical diagnosis. The physician has to have suspicion and experience in determining if it's worth treating," Mr. Telford said. "The tests have to go hand-in-hand with the clinical observation. The clinical observation goes first but there is no one best test. Each laboratory has their own way of doing it. However, all of them follow what we call the two-tier protocol or the CDC guidelines. And, the reason for this is that is what our knowledge is based on."